Treatment of asymptomatic candidiasis in pregnant women for the prevention of preterm birth: a randomised trial

INTERVENTION: Clotrimazole vaginal pessaries (100 mg) for daily use for 6 days. Women will be advised to insert one pessary as gently and deeply as possible into the vagina while lying on her back, preferably at night, for 6 nights. CONDITION: Asymptomatic candidiasis Preterm birth PRIMARY OUTCOME: 1: Preterm birth between 20+0 to 36+6 weeks gestation following spontaneous onset of labour or following preterm prelabour rupture of membranes (PPROM). ; http://hdl.handle.net/2123/15426 SECONDARY OUTCOME: A composite neonatal morbidity indicator including respiratory distress, assisted ventilation, intraventricular haemorrhage, necrotising enterocolitis, retinopathy and pneumonia. ; Lain et al, Maternal Child Health Journal 2012; 16(3): 600‐8 Admission to neonatal intensive care unit At birth any preterm birth, medically indicated preterm birth (including indication), preterm birth between 20+0 to 31+ 6 weeks, preterm prelabour rupture of the membranes, spontaneous pregnancy loss <20 weeks gestation, fetal growth restriction (<10th birthweight for gestational age percentile), birth weight, Apgar score at 5 minutes (an indicator of the health status of the newborn infant). ; http://hdl.handle.net/2123/15426 Maternal length of stay (LOS) for delivery admission Neonatal length of stay (LOS) Perinatal mortality (births > = 20+0 weeks resulting in either stillbirth or neonatal death) Pregnancy hypertension, gestational diabetes, antepartum haemorrhage, placental abnornmalities, fetal malformations, onset of labour, mode of delivery Symptoms of candidiasis, use of antibiotics and /or corticosteroids, treatment of candidiasis, compliance with the treatment regimen and treatment side effects. INCLUSION CRITERIA: Pregnant women presenting for antenatal care between 12+0 and 19+6 weeks gestation with singleton pregnancies and asymptomatic candidiasis